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Eeva™ Pregnancy Investigational Clinical Study: A Postmarket Follow-Up Study (EPIC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01671644
First Posted: August 23, 2012
Last Update Posted: October 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Progyny, Inc.
  Purpose
The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates.

Condition
Infertility

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Eeva™ Pregnancy Investigational Clinical Study: A Postmarket Follow-Up Study

Further study details as provided by Progyny, Inc.:

Primary Outcome Measures:
  • Rate of clinical pregnancy [ Time Frame: 5-8 weeks gestational age ]
    To compare the rate of clinical pregnancy at approximately 5-8 weeks gestational age for the Day 3 embryo transfers that used Eeva predictions with morphology grading to that for Day 3 embryo transfers using morphology grading only (from a matched concurrent control group at each clinical site comprised of year 2011-2013 patients).


Secondary Outcome Measures:
  • Implantation rate (# of implanted embryos out of # of total embryos transferred) [ Time Frame: 5-8 weeks gestational age. ]
  • Ongoing Pregnancy Rate (gestational week 10-12) [ Time Frame: Gestational age week 10-12 ]
  • Multiple pregnancy rate [ Time Frame: Gestational weeks 5-8 and 10-12 ]
  • Spontaneous miscarriage rate [ Time Frame: Gestational age week 10-12 ]

Enrollment: 104
Study Start Date: February 2013
Study Completion Date: October 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Eeva Test Group
Day 3 embryo transfers that used Eeva predictions with morphology grading.
Matched case control group
Day 3 embryo transfers using morphology grading only (from a matched concurrent control group).

Detailed Description:
The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates, as compared to a matched case control group that used morphology grading only to select embryos for transfer.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing in vitro fertilization treatment who provide informed consent and plan to undergo Day 3 embryo transfer.
Criteria

Inclusion Criteria:

  • Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
  • IVF cycle attempts ≤ 3.
  • Egg age ≤ 40 years.
  • Planned Day 3 embryo transfer.
  • At least 5 normally fertilized eggs (2PN).
  • All 2PN embryos must be imaged by Eeva.
  • Normal uterine cavity as evaluated by standard methods.
  • Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
  • Willing to comply with study protocol and procedures.
  • Willing to provide written informed consent.

Exclusion Criteria:

  • Planned preimplantation genetic diagnosis.
  • Planned "freeze all" cycle (oocytes or embryos).
  • Concurrent participation in another clinical study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671644


Locations
Belgium
Gent University Hospital
Gent, East Flanders, Belgium, 9000 Gent
Netherlands
VU University Medical Center
Amsterdam, South Holland, Netherlands, 2500 BH
Sponsors and Collaborators
Progyny, Inc.
Investigators
Study Director: Shehua Shen, MD, ELD Progyny, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Progyny, Inc.
ClinicalTrials.gov Identifier: NCT01671644     History of Changes
Other Study ID Numbers: 2012-AUX-005
TST-1872-p ( Other Identifier: Auxogyn )
First Submitted: August 21, 2012
First Posted: August 23, 2012
Last Update Posted: October 20, 2015
Last Verified: October 2015

Keywords provided by Progyny, Inc.:
In vitro fertilization
Assisted reproductive therapy
Time-lapse image recording
Image analysis software

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female